GUEST COLUMNISTS

• No, Biologics Are Not Natural Monopolies

  Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.

• Illuminating the Need for Standards in Regenerative Medicine and Advanced Therapy

  In the past, standards development in the life sciences has required years. This can be attributed to the passive process which has been primarily based on volunteer contributors from industry. The Standards Coordinating Body (SCB) accelerates the process by focusing on high priority/high impact standards and catalyzing the process. 

• Are You Approaching LIMS Validation Correctly?

  Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.

• Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs

  The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits. 

• The Potential And Future Of Cell Therapy

  While the field has made laudable progress in developing novel biomolecules that can be used to control cell function (e.g. mRNA, DNA, CRISPR, siRNA, proteins, peptides, etc.), very little progress has been made on reliably delivering these materials to a cell and enabling robust engineering of cell function without significantly impairing cell health. 

• An Analysis Of The Gene Therapy Viral Vector Landscape

  Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.

• Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm

  Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.

• Making Sense Of Antibody Epitope Claims

  Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.